Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001494729
Ethics application status
Approved
Date submitted
15/11/2022
Date registered
29/11/2022
Date last updated
13/10/2024
Date data sharing statement initially provided
29/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising Care: Supporting women with metastatic breast cancer to optimise their quality of life via exercise and diet
Scientific title
Optimising Care: Phase III Trial in women with metastatic breast cancer to optimise their quality of life via exercise and diet
Secondary ID [1] 308193 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
metastatic breast cancer 327934 0
Condition category
Condition code
Cancer 325002 325002 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the Optimising Care intervention arm will receive a 12-month exercise and dietary intervention, delivered using an eHealth model (i.e., video-platform based on participant preference: Zoom, Teams) by an Accredited Exercise Physiologist (AEP) and Accredited Practicing Dietitian (APD). The intervention will be individually tailored (based on sites of metastatic disease, treatment-related side-effects, baseline assessment of outcomes, and pre-screening questions). Tailoring may include the number, frequency, and timing of sessions. Participants will have access to a maximum of 10 AEP sessions and 10 APD sessions over the 12-month intervention period. All sessions will be delivered one-on-one with the health professional, scheduled at a day and time convenient to the participant. Initial AEP and APD sessions will be approximately 1 hour each, with follow-up sessions approximately 30-45 mins in duration.

Participants will be provided with a study workbook and logbook that outlines content delivered in sessions and the prescribed exercises, and helps participants keep track of the activities completed in between sessions. Participants will also be provided with resistance bands to assist with strength-based exercises at home.

The exercise intervention will focus on increasing aerobic-based and resistance-based exercise (body weight, resistance bands or weights) activities, with a goal of achieving greater than or equal to 150 minutes of activity per week moderate intensity or higher and including 2 sessions of resistance exercises. The weekly exercise prescription, including the type, intensity and duration will be tailored to the individual. Common exercise to be prescribed will likely be walking and stationary cycling, as well as resistance exercises using resistance bands provided for home use. Exercise intensity will be recorded in the Logbook using the Rating of Perceived Exertion (RPE) Scale.

The Dietitian will work with participants to make sure that they are eating well (e.g., sufficient protein intake) with a focus on improving your overall diet quality and helping to manage symptoms.

Adherence to exercise and diet sessions (e.g., attendance, compliance to the prescribed exercises) will be recorded by the AEP in the case management file during eHealth sessions.
Intervention code [1] 324646 0
Treatment: Other
Intervention code [2] 324954 0
Behaviour
Comparator / control treatment
Participants allocated to the Current Practice control arm will receive usual care from their treating clinicians and will be encouraged to access existing services and resources (e.g., Breast Cancer Network Australia (BCNA)’s online tool to receive information and resources in relation to exercise and nutrition). The My Journey online tool is available to all Australian women diagnosed with breast cancer (https://www.bcna.org.au/understanding-breast-cancer/bcna-resources/my-journey/). The resources tailored to women with metastatic breast cancer have been updated by the research team as part of this study. The online tool also informs women of other existing community-based or online support options, including accessing support to allied health services (e.g., APD and AEP) through a General Practitioner (GP)-coordinated Chronic Disease Management (CDM) Plan.
Control group
Active

Outcomes
Primary outcome [1] 333018 0
Self-reported physical function as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30; version 3.0) – physical functioning scale.
Timepoint [1] 333018 0
Self-reported physical function will be assessed at baseline, 3-months, 6-months (6M; mid-intervention), 9-months, and 12-months (12M; end-of-intervention; primary time point).
Primary outcome [2] 333019 0
Whole body lean mass as measured by Dual-energy X-ray Absorptiometry (DXA) body scan.
Timepoint [2] 333019 0
Whole body lean mass will be assessed at baseline, 6-months (6M; mid-intervention), and 12-months (12M; end-of-intervention; primary time point).
Secondary outcome [1] 415558 0
Whole body fat mass as measured by DXA body scan.
Timepoint [1] 415558 0
Whole body fat mass will be assessed at baseline, 6-months (6M; mid-intervention), and 12-months (12M; end-of-intervention).
Secondary outcome [2] 415559 0
Appendicular lean mass as measured by DXA body scan.
Timepoint [2] 415559 0
Appendicular lean mass will be assessed at baseline, 6-months (6M; mid-intervention), and 12-months (12M; end-of-intervention).
Secondary outcome [3] 415560 0
Role functioning as measured by the EORTC QLQ-C30 (version 3.0) – role functioning scale.
Timepoint [3] 415560 0
Role functioning will be assessed at baseline, 3-months, 6-months (6M; mid-intervention), 9-months, and 12-months (12M; end-of-intervention).
Secondary outcome [4] 415561 0
Emotional functioning as measured by the EORTC QLQ-C30 (version 3.0) – emotional functioning scale.
Timepoint [4] 415561 0
Emotional functioning will be assessed at baseline, 3-months, 6-months (6M; mid-intervention), 9-months, and 12-months (12M; end-of-intervention).
Secondary outcome [5] 415562 0
Cognitive functioning as measured by the EORTC QLQ-C30 (version 3.0) – cognitive functioning scale.
Timepoint [5] 415562 0
Cognitive functioning will be assessed at baseline, 3-months, 6-months (6M; mid-intervention), 9-months, and 12-months (12M; end-of-intervention).
Secondary outcome [6] 415563 0
Social functioning as measured by the EORTC QLQ-C30 (version 3.0) – social functioning scale.
Timepoint [6] 415563 0
Social functioning will be assessed at baseline, 3-months, 6-months (6M; mid-intervention), 9-months, and 12-months (12M; end-of-intervention).
Secondary outcome [7] 415565 0
Overall quality of life as measured by a single item in the EORTC QLQ-C30 (version 3.0).
Timepoint [7] 415565 0
Overall quality of life will be assessed at baseline, 3-months, 6-months (6M; mid-intervention), 9-months, and 12-months (12M; end-of-intervention).
Secondary outcome [8] 415567 0
Global health status as measured by a single item in the EORTC QLQ-C30 (version 3.0).
Timepoint [8] 415567 0
Global health status will be assessed at baseline, 3-months, 6-months (6M; mid-intervention), 9-months, and 12-months (12M; end-of-intervention).
Secondary outcome [9] 415568 0
Fatigue as measured by the EORTC QLQ-C30 (version 3.0) – fatigue scale.
Timepoint [9] 415568 0
Fatigue will be assessed at baseline, 3-months, 6-months (6M; mid-intervention), 9-months, and 12-months (12M; end-of-intervention).
Secondary outcome [10] 415569 0
Nausea and vomiting as measured by the EORTC QLQ-C30 (version 3.0) – nausea and vomiting scale.
Timepoint [10] 415569 0
Nausea and vomiting will be assessed at baseline, 3-months, 6-months (6M; mid-intervention), 9-months, and 12-months (12M; end-of-intervention).
Secondary outcome [11] 415570 0
Pain as measured by the EORTC QLQ-C30 (version 3.0) – pain scale.
Timepoint [11] 415570 0
Pain will be assessed at baseline, 3-months, 6-months (6M; mid-intervention), 9-months, and 12-months (12M; end-of-intervention).
Secondary outcome [12] 415571 0
Dyspnoea as measured by a single item in the EORTC QLQ-C30 (version 3.0).
Timepoint [12] 415571 0
Dyspnoea will be assessed at baseline, 3-months, 6-months (6M; mid-intervention), 9-months, and 12-months (12M; end-of-intervention).
Secondary outcome [13] 416040 0
Insomnia as measured by a single item in the EORTC QLQ-C30 (version 3.0).
Timepoint [13] 416040 0
Insomnia will be assessed at baseline, 3-months, 6-months (6M; mid-intervention), 9-months, and 12-months (12M; end-of-intervention).
Secondary outcome [14] 416041 0
Appetite loss as measured by a single item in the EORTC QLQ-C30 (version 3.0).
Timepoint [14] 416041 0
Appetite loss will be assessed at baseline, 3-months, 6-months (6M; mid-intervention), 9-months, and 12-months (12M; end-of-intervention).
Secondary outcome [15] 416042 0
Constipation as measured by a single item in the EORTC QLQ-C30 (version 3.0).
Timepoint [15] 416042 0
Constipation will be assessed at baseline, 3-months, 6-months (6M; mid-intervention), 9-months, and 12-months (12M; end-of-intervention).
Secondary outcome [16] 416043 0
Diarrhoea as measured by a single item in the EORTC QLQ-C30 (version 3.0).
Timepoint [16] 416043 0
Diarrhoea will be assessed at baseline, 3-months, 6-months (6M; mid-intervention), 9-months, and 12-months (12M; end-of-intervention).
Secondary outcome [17] 416044 0
Fatigue as measured by the FACIT-Fatigue Subscale (version 4.0).
Timepoint [17] 416044 0
Fatigue will be assessed at baseline, 6-months (6M; mid-intervention), and 12-months (12M; end-of-intervention).
Secondary outcome [18] 416045 0
Pain interference as measured by the PROMIS-Pain Interference Subscale (version 1.1).
Timepoint [18] 416045 0
Pain interference will be assessed at baseline, 6-months (6M; mid-intervention), and 12-months (12M; end-of-intervention).
Secondary outcome [19] 416046 0
Pain intensity as measured by the single-item PROMIS-Pain Intensity (version 1.0).
Timepoint [19] 416046 0
Pain Intensity will be assessed at baseline, 6-months (6M; mid-intervention), and 12-months (12M; end-of-intervention).
Secondary outcome [20] 416131 0
Fitness as assessed by the 2-minute step test.
Timepoint [20] 416131 0
Fitness will be assessed at baseline, 6-months (6M; mid-intervention), and 12-months (12M; end-of-intervention).
Secondary outcome [21] 416132 0
Performance-based physical function as assessed by the 30-second sit-stand test.
Timepoint [21] 416132 0
Performance-based physical function will be assessed at baseline, 6-months (6M; mid-intervention), and 12-months (12M; end-of-intervention; primary time point).
Secondary outcome [22] 416136 0
Anxiety as measured by the Hospital Anxiety and Depression Scale (HADS; version 5.0).
Timepoint [22] 416136 0
Anxiety will be assessed at baseline, 6-months (6M; mid-intervention), and 12-months (12M; end-of-intervention).
Secondary outcome [23] 416137 0
Depression as measured by the Hospital Anxiety and Depression Scale (HADS; version 5.0).
Timepoint [23] 416137 0
Depression will be assessed at baseline, 6-months (6M; mid-intervention), and 12-months (12M; end-of-intervention).
Secondary outcome [24] 426557 0
Distress as measured by the single-item Distress Thermometer (version 1.0).
Timepoint [24] 426557 0
Distress will be assessed at baseline, 3-months, 6-months (6M; mid-intervention), 9-months, and 12-months (12M; end-of-intervention; primary time point).
Secondary outcome [25] 426558 0
Perceived stress as measured by the Perceived Stress Scale (PSS; version 1.0).
Timepoint [25] 426558 0
Perceived stress will be assessed at baseline, 6-months (6M; mid-intervention), and 12-months (12M; end-of-intervention; primary time point).
Secondary outcome [26] 426559 0
Performance status as measured by a single item in the ECOG Performance Status Scale (version 1.0).
Timepoint [26] 426559 0
Performance status will be assessed at baseline, 3-months, 6-months (6M; mid-intervention), 9-months, and 12-months (12M; end-of-intervention; primary time point).
Secondary outcome [27] 426560 0
Financial difficulties as measured by a single item in the EORTC QLQ-C30 (version 3.0).
Timepoint [27] 426560 0
Financial difficulties will be assessed at baseline, 3-months, 6-months (6M; mid-intervention), 9-months, and 12-months (12M; end-of-intervention; primary time point).
Secondary outcome [28] 426561 0
Health care utilisation (e.g., exercise physiologist, dietitian) as measured by items developed specifically for this study (adapted from previous work by CI Gordon, Health Economist).
Timepoint [28] 426561 0
Health care utilisation will be assessed at baseline, 6-months (6M; mid-intervention), and 12-months (12M; end-of-intervention).
Secondary outcome [29] 426562 0
Health care costs of specific services (e.g., exercise physiologist, dietitian) as measured by items developed specifically for this study (adapted from previous work by CI Gordon, Health Economist).
Timepoint [29] 426562 0
Health care costs will be assessed at baseline, 6-months (6M; mid-intervention), and 12-months (12M; end-of-intervention).
Secondary outcome [30] 426563 0
Adverse events (AEs) according to the CTC-AE version 5 (Common Terminology Criteria for Adverse Events) criteria.
Timepoint [30] 426563 0
Adverse events will be self-reported at 6-months (6M; mid-intervention), and 12-months (12M; end-of-intervention) and during the study period as they arise.
Secondary outcome [31] 426564 0
Adverse events related to the study according to the WHO-UMC system for standardised case causality assessments..
Timepoint [31] 426564 0
Adverse events will be self-reported at 6-months (6M; mid-intervention), and 12-months (12M; end-of-intervention) and during the study period as they arise.
Secondary outcome [32] 426565 0
Serious adverse events (SAEs) will be classified as serious if graded 3-5 according to the CTC-AE version 5 criteria.
Timepoint [32] 426565 0
Adverse events will be self-reported at 6-months (6M; mid-intervention), and 12-months (12M; end-of-intervention) and during the study period as they arise.
Secondary outcome [33] 426566 0
Serious adverse events related to the study according to the WHO-UMC system for standardised case causality assessments..
Timepoint [33] 426566 0
Adverse events will be self-reported at 6-months (6M; mid-intervention), and 12-months (12M; end-of-intervention) and during the study period as they arise.
Secondary outcome [34] 426567 0
Disease progression will be defined as changes to cancer treatment, hospital admission codes including palliative care codes, and/or death based on data linkage (e.g., PBS, hospital admissions, death register). Changes to cancer treatment will also be self-reported at 6 months and 12 months.
Timepoint [34] 426567 0
Disease progression will be assessed over the 12-month study period.
Secondary outcome [35] 426568 0
Moderate-to-vigorous physical activity (MVPA; minutes per week) as measured by the Active Australia Survey (AAS); 1997 version modified for self-report data collection by the Australian Longitudinal Study on Women’s Health (ALSWH) 1989-95 Cohort Survey 6.
Timepoint [35] 426568 0
MVPA will be assessed at baseline, 6-months (6M; mid-intervention), and 12-months (12M; end-of-intervention).
Secondary outcome [36] 426569 0
Strength-based physical activity (minutes per week) as measured by the AAS; 1997 version modified for self-report data collection by the Australian Longitudinal Study on Women’s Health (ALSWH) 1989-95 Cohort Survey 6.
Timepoint [36] 426569 0
Strength-based physical activity will be assessed at baseline, 6-months (6M; mid-intervention), and 12-months (12M; end-of-intervention).
Secondary outcome [37] 426570 0
Dietary energy intake (kJ per day) will be assessed using the web-based, Automated Self-Administered 24-hour dietary recall (ASA24)-Australia. Participants will complete two 24-dietary recalls (one weekday and one weekend day), which will be used to calculate a daily average.
Timepoint [37] 426570 0
Dietary energy intake will be assessed at baseline, 6-months (6M; mid-intervention), and 12-months (12M; end-of-intervention).
Secondary outcome [38] 426571 0
Dietary protein intake (grams per day) will be assessed using the web-based, Automated Self-Administered 24-hour dietary recall (ASA24)-Australia. Participants will complete two 24-dietary recalls (one weekday and one weekend day), which will be used to calculate a daily average.
Timepoint [38] 426571 0
Dietary protein intake will be assessed at baseline, 6-months (6M; mid-intervention), and 12-months (12M; end-of-intervention).
Secondary outcome [39] 426572 0
Participant experience as measured by the adapted Australian Hospital Patient Experience Question Set (AHPEQS) total score.
Timepoint [39] 426572 0
Participant experience will be assessed at 6-months (6M; mid-intervention), and 12-months (12M; end-of-intervention).

Eligibility
Key inclusion criteria
Eligibility will be based on the following inclusion criteria:
1. Women
2. Aged 18 years or older
3. Diagnosed with MBC in previous 10 years
4. Reside in Queensland, Australia
5. Eastern Cooperative Oncology Group (ECOG) Performance status 0-2 (self-reported by women, i.e., 0 indicates fully active, able to carry on all pre-disease performance without restriction; 1 indicates restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work; or 2 indicates ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Few exclusion criteria will be applied to ensure broad generalisability of the sample, consistent with the pragmatic design. Women will be excluded only if they meet any of the following criteria:
1. Contraindications to participation in an exercise and dietary intervention (e.g., unstable angina, severe psychiatric condition)
2. Insufficient English to complete data collection and participate in the intervention

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once generated, the randomisation sequence will be concealed from staff involved in recruitment (uploaded to REDCap via the randomisation module).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be computer-generated using STATA by an independent statistician with varying block sizes. Randomisation will be stratified by metastatic disease type (de novo vs recurrent), spread (non-visceral metastases only; Yes vs. No) and geographical location (Metropolitan vs Regional/ Remote).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size calculation: Based on detecting a minimum clinically important difference of ½ SD between the Optimising Care intervention and current practice groups for the primary outcome of self-reported physical function (EORTC QLQ-C30) at 12-months, with 80% power and 5% significance (two-tailed). Allowing for 35% attrition, based on our pilot study and assuming fewer disease progressions with recruitment closer to diagnosis, a total of 200 women (100 per group) will be recruited. With this sample size we will have 94% power to detect a between-group difference in change in lean mass of 1 kg, with a SD of change from our pilot study of 1.6 kg. This magnitude of difference is likely to be clinically meaningful and feasible to achieve. The sample size will provide 80% power to detect effect sizes of ½ SD in secondary outcomes. We have assumed no differential attrition between study arms based on CI Hayes’ current exercise trial (vs control) in women with ovarian cancer who have similar poor prognosis.

Sample size feasibility: The sample size will be feasible to recruit via the Queensland Oncology Repository over the 2-year recruitment period. Of the approx. 4,000 Qld women diagnosed with breast cancer each year, 4.6% will be diagnosed with de novo MBC. Conservatively estimating that approximately 10% of women diagnosed with early-stage breast cancer previously, will be diagnosed with recurrent MBC each year, we estimate another ~380 Qld women diagnosed with MBC (n=555 per year in Qld). Estimating that 45% may deem themselves ineligible due to prognosis and conservatively estimating a 50% recruitment rate across the two-stage consent process (approx. 152 per year), we will be able to recruit our sample of 200 women within the 2-year recruitment period.

Statistical methods: Intention to treat analyses and per-protocol sensitivity analyses will be used. The statistical analysis plan includes the use of linear mixed models for the primary outcomes (and secondary outcomes) using all available data. Analysis code will be written and agreed using pooled data before knowledge of group allocation is provided. There will be no formal adjustment for multiple testing, though results will be interpreted with multiple testing in mind. Statistical significance will be set at p<0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/09/2023
Actual
4/10/2023
Date of last participant enrolment
Anticipated
7/07/2025
Actual
Date of last data collection
Anticipated
3/08/2026
Actual
Sample size
Target
200
Accrual to date
64
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 25901 0
Cairns Hospital - Cairns
Recruitment hospital [2] 25902 0
Gold Coast University Hospital - Southport
Recruitment hospital [3] 25903 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [4] 25904 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 25905 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [6] 26210 0
Ipswich Hospital - Ipswich
Recruitment hospital [7] 26211 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [8] 26212 0
The Prince Charles Hospital - Chermside
Recruitment hospital [9] 26898 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [10] 26899 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [11] 26900 0
St Andrew's Toowoomba Hospital - Toowoomba
Recruitment hospital [12] 27209 0
Icon Cancer Care Wesley - Auchenflower
Recruitment hospital [13] 27210 0
St Vincent's Private Hospital Northside - Chermside
Recruitment hospital [14] 27211 0
North Lakes Health Precinct - North Lakes
Recruitment hospital [15] 27212 0
Mater Private Hospital Brisbane - South Brisbane
Recruitment postcode(s) [1] 41736 0
4870 - Cairns
Recruitment postcode(s) [2] 41737 0
4215 - Southport
Recruitment postcode(s) [3] 41738 0
4101 - South Brisbane
Recruitment postcode(s) [4] 41739 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 41740 0
4029 - Herston
Recruitment postcode(s) [6] 42176 0
4305 - Ipswich
Recruitment postcode(s) [7] 42177 0
4575 - Birtinya
Recruitment postcode(s) [8] 42178 0
4032 - Chermside
Recruitment postcode(s) [9] 42957 0
4020 - Redcliffe
Recruitment postcode(s) [10] 42958 0
4350 - Toowoomba
Recruitment postcode(s) [11] 43293 0
4066 - Auchenflower
Recruitment postcode(s) [12] 43294 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 312448 0
Government body
Name [1] 312448 0
Australian Government (Department of Health and Aged Care) Medical Research Future Fund (MRFF)
Country [1] 312448 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
Faculty of Medicine, Mayne Medical School
20 Weightman St
Herston QLD 4006
Country
Australia
Secondary sponsor category [1] 314200 0
None
Name [1] 314200 0
Address [1] 314200 0
Country [1] 314200 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311794 0
Metro South Health Human Research Ethics Committee
Ethics committee address [1] 311794 0
Ethics committee country [1] 311794 0
Australia
Date submitted for ethics approval [1] 311794 0
16/11/2022
Approval date [1] 311794 0
03/01/2023
Ethics approval number [1] 311794 0
HREC/2022/QMS/89482

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122390 0
Prof Marina Reeves
Address 122390 0
The University of Queensland
School of Public Health, The University of Queensland, Public Health Building
Herston Rd
Herston QLD 4006
Country 122390 0
Australia
Phone 122390 0
+61 07 3346 4692
Fax 122390 0
Email 122390 0
[email protected]
Contact person for public queries
Name 122391 0
Marina Reeves
Address 122391 0
The University of Queensland
School of Public Health, The University of Queensland, Public Health Building
Herston Rd
Herston QLD 4006
Country 122391 0
Australia
Phone 122391 0
+61 07 3346 4692
Fax 122391 0
Email 122391 0
[email protected]
Contact person for scientific queries
Name 122392 0
Marina Reeves
Address 122392 0
The University of Queensland
School of Public Health, The University of Queensland, Public Health Building
Herston Rd
Herston QLD 4006
Country 122392 0
Australia
Phone 122392 0
+61 07 3346 4692
Fax 122392 0
Email 122392 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Researchers will be able to contact the Chief Investigator for access to data. Data will be maintained in a csv format to enable open re-use of the data. Data available will be all of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following main results publication; no end date determined.
Available to whom?
Case-by-case basis at the discretion of Chief Investigator
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.